The initial situation must be known at the start of a project. This is the only way to assure an efficient planning and implementation! Axxos supports you with preparatory audits, as-is or gap analyses.

Equipment qualification and process validation are crucial requirements in the manufacture of medical devices. The validity of processes is checked in detail, particularly during audits by customers, notified bodies or FDA inspections.

Over the years, Axxos has built up extensive knowledge in the validation of all medical device production processes. Clever qualification and validation approaches are of maximum benefit to the company and fulfill the applicable normative and regulatory requirements. As a pleasant side effect, scattering is reduced and know-how about the company’s own processes increases.
The result is continuously high-quality processes that stand up to every audit.

Computer System Validation (CSV) creates practical added value by putting the software through its paces to meet your requirements and providing documented proof of it. If the software requires an update, the same test plans can usually be used again. It goes without saying that the normative and legal requirements of the GxP-regulated environment for the reliability, accuracy, security and integrity of a computer system are met.

With Axxos, computer system validation becomes an almost playful process and loses its aura of being unachievable. In addition to the basic fulfillment of regulatory requirements, the focus is always on practical relevance and efficiency in terms of cost and effort.

The credibility of test and inspection results is crucial – not only in quality assurance, but also in preclinical testing, verification and validation. Testing and calibration laboratories play a decisive role here. Validated test methods are just as important as the independence and reliability of the laboratory itself.

Whether products are tested in the own laboratory or by third-party providers, the experts at Axxos provide support in ensuring that the relevant processes work efficiently, the results are reliable and the requirements of ISO 17025 are met.

Our extensive expertise ranges from the conceptual development of the entire quality management system for a test laboratory to the qualification of test equipment or the validation of corresponding test methods.

From 510(k) to FDA inspection support, Axxos has many years of hands-on experience in complying with and implementing FDA medical device requirements.

The requirements for healthcare facilities and institutions are diverse. An efficient quality management system is the key to successful audits or Swissmedic inspections. Axxos supports in implementing the requirements of Swissmedic or the canton in the quality management system in a user-friendly and practical way.

Both manufacturers and users of medical devices can be inspected by the authorities (Swissmedic, cantons) at any time. For hospitals, it should be noted that increased inspections by Swissmedic are to be expected. We therefore recommend that all medical device manufacturers, healthcare facilities, hospitals, etc. prepare systematically and specifically for an inspection in order to prevent serious consequences.
Axxos offers support in the following areas:

• GAP analysis regarding the relevant legal requirements (e.g. GPA / MedDO) to identify potential gaps
• Development of pragmatic and legally compliant solutions and support during the implementation.
• Preparation and active support during an inspection
• Supporting the follow-upactivities of such an inspection
• Ensuring the efficient and sustainable processing/elimination of identified deviations
• Supporting adequate communication with the authorities.

There are many applicable laws, standards and guidance documents in the medical device industry. The Axxos update service monitors and summarizes the changes in a comprehensible annual or semi-annual report.